Gottlieb’s replacement? A roundup of likely, possible, and you-never-know contenders

BySTAT staff

March 7, 2019

FDA Commissioner Scott GottliebZach Gibson/Getty Images

The sudden resignation of Scott Gottlieb, the commissioner of the Food and Drug Administration, leaves a giant hole atop an agency that oversees a quarter of the U.S. economy. Which, of course, leads to an equally big question: Who will replace him?

This is actually a two-part question. First, the administration will likely decide on an acting commissioner, who can take control when Gottlieb departs in a month. Then comes the harder task of finding a nominee who can be confirmed by the Senate. It would not be unprecedented for an administration facing other battles to leave the acting commissioner in place for months — or longer. There might not be a new commissioner until after 2020.

“I’ve expressed my thoughts privately and I’ll keep them private. I think that there’s some good people being thought of for the acting position,” Gottlieb said at a Wednesday event hosted by The Hill. “In terms of a nominee that’s obviously a longer process and I don’t think they’re at the point of making decisions around that yet. But I think in terms of who steps in to fill the role in an acting capacity there’s some good names in the mix.”

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So who steps in? Who knows. But we’re happy to fill the speculation vacuum. We’ve broken the list below into three main groups: the likely contenders, the “it’s possible” picks, and the complete wild cards.

The contenders (at least for now)

Amy Abernethy

Abernethy, formerly the chief medical officer at health data firm Flatiron Health, which is now part of Roche, became Gottlieb’s principal deputy commissioner early this year. In a note to investors, analysts at Cowen call her “the likely interim leader.” Abernethy was brought on board to rethink how the FDA handles the streams of data pouring out from new, digital approaches to medicine. As a researcher, she used data from electronic medical records to show that oxygen tanks might not help patients with shortness of breath and helped create a data network with the American Society of Clinical Oncology. At Duke, where she spent her academic career, former FDA Commissioner Robert Califf was a mentor. When Abernethy’s role at the FDA was announced, Gottlieb praised “her intellect, her passion for patient care and science, and her collegiality.”

Her short tenure could work against her, as could her lack of experience in other areas the FDA regulates, like blood products. On the other hand, she is, after all, the principal deputy commissioner.

Ned Sharpless

Sharpless, the director of the National Cancer Institute since October 2017, would bring a deep knowledge of biotech to an FDA stint. Sharpless previously ran the University of North Carolina’s Lineberger Comprehensive Cancer Center, where he was a physician-scientist, running a lab and treating patients. He was, and is, known as a believer in the power of big data to accelerate drug discovery by streamlining clinical trials. He co-founded two clinical-stage biotechs: G1 Therapeutics, a developer of cancer drugs that raised $108.6 million in a 2017 initial public offering, and HealthSpan Diagnostics, a developer of blood tests. UNC colleagues remember him as someone “who had bold visions and turned them over to people to do a great job of executing,” said one. “He trusts the people he hires to do a great job.” He has been an enthusiastic backer (via Twitter) of Gottlieb’s efforts on tobacco and e-cigarettes.

Brett Giroir

Giroir, the current HHS assistant secretary for health, checks many of the boxes typically requested of an FDA commissioner. Most notably: He has experience in government, academia, and industry. The pediatrician turned professor turned biotech-startup-CEO turned bureaucrat has led much of HHS’s opioid work in the Trump administration — work that obviously dovetails with that of an FDA commissioner.

But his tenure in the Trump administration got off to a particularly rocky start after Democrats became concerned he would be a partisan on the issue of women’s health, an issue in an agency where controversy over making the Plan B birth control pill over the counter is still raw, years later. He was a national high school debate champion, so you know his confirmation hearings would be a hoot.

It could happen …

Janet Woodcock

Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, is a powerful figure inside the agency, where she’s worked since 1986. She’s also skilled at testifying on Capitol Hill — a necessary talent when Democrats hold the House. Besides being a long-standing regulator, she was trained as a chemist and has a medical degree, and that has meant her name is almost always mentioned when a new FDA commissioner is needed.

But Woodcock spent the past two years working on a new organization and enhancements for the FDA’s core new drug review operations. Cowen analysts speculated that finishing those efforts could mark a moment for her to retire. It’s also worth noting that commissioners, who are political appointees, have not previously been recruited from the FDA career staff.

McClellan not only served as FDA commissioner under George W. Bush, he also ran the Centers for Medicare and Medicaid Services. His credentials make him a shoo-in for the job, should it be offered to him. McClellan is also perhaps the only person in Washington who can rival Gottlieb’s enthusiasm when talking about the strange interactions between biosimilars and drug rebates. And while McClellan is still regularly pumping out ideas on how to reform the FDA and bring down health care costs as part of his current role at Duke University, he has largely stepped away from the limelight as Gottlieb, his former deputy, helmed the agency. But would someone who already ran both the FDA and CMS really want his old job back, two decades later?

Jerome Adams

Like Gottlieb, Adams, the surgeon general, is another Trump administration figure popular in public health circles. (There aren’t many.) He and Gottlieb also share some of the same public health concerns, namely youth e-cigarette use and addiction. But unlike Gottlieb, Adams lacks prior experience at the FDA or in the broader drug development world. Before being nominated as surgeon general by President Trump, Adams was an anesthesiologist and then the health commissioner in Indiana (under then-Gov. Mike Pence).

His nomination feels unlikely, in part because Adams seems to enjoy getting to travel the country and highlight his priorities, including the importance of carrying the opioid overdose reversal medication naloxone and the link between public health and the economy. But one thing to keep in mind: Whereas Adams’ role gives him a fairly prominent pulpit to speak from, it is largely just that. Running the FDA comes with a lot of regulatory power.

We admit it. Anything could happen.

Jim O’Neill

Like Gottlieb, O’Neill has experience in the Department of Health and Human Services. He’s a former HHS principal associate deputy secretary. But unlike the outgoing FDA commissioner, he seems to have little interest in how the agency traditionally works. Instead, O’Neill is a staunch libertarian who has said that the FDA shouldn’t require drug companies to prove new medicines are effective before approving them. As long as treatments seem safe enough, O’Neill argued in 2014, patients should be able to use them at their own risk. He doesn’t have any medical training or scientific expertise, but he is aligned with billionaire investor Peter Thiel, who was an adviser to Trump back in 2016 when O’Neill was on the short list for FDA commissioner. Before Gottlieb was nominated, O’Neill’s name scared industry insiders who feared there could be too much deregulation. Expect a similar reaction if it surfaces again.

Joe Gulfo

Gulfo surfaced as a potential nominee back in 2016 while advocating for sweeping changes to how the FDA regulates drugs and medical devices, based in part on his own experiences as chief executive of a diagnostics startup. In a series of publications and speeches, Gulfo has laid out a four-tier system for approving new medicines, the highest of which would be reserved for drugs that have demonstrated lasting benefits to patients, while the lowest would apply to therapies that have showed only hints of efficacy. That, he argued, would incentivize drug companies to gradually prove out the long-term promise of their products while allowing doctors and patients to decide for themselves in the meantime. Gulfo, a member of the faculty at Fairleigh Dickinson University, has in the past expressed his admiration for Trump despite a series of retweets of statements criticizing the president. Those posts were made in error, Gulfo said.

Thank you for posting this well-informed article. As I read through the suggested candidates for the top position at the Food and Drug Administration, I couldn’t help but wonder what each of these candidates brings to the table in terms of managing our FOOD supply. The US imports the lions share of its food, and it’s my understanding that the FDA inspects a very small percentage. Yes, drugs must be properly regulated, but let us not forget..we are what we eat!